Archive | Audio & Video

Teva committed to QbD methodology implementation in late 2010. Inna Ben-Anat, QbD Strategy Leader, leads the ‎implementation at Teva’s global generic R&D from Sellersville, Pennsylvania. Inna, together with Yatindra Joshi, VP Global GR&D for the US market, and Uri Hillel, Head of Quality, Global R&D, implemented the global QbD training program. This program supports R&D teams in developing QbD strategies and optimizing formulations and processes using statistical tools; assisting in the development of robust product specifications.

Arvindh Balakrishnan, Former VP of Life Sciences, Oracle and Russ Somma, President, SommaTech LLC discuss the components of characteristics of modern and effective technology transfer. New approaches and more comprehensive outlooks are vital to product/process understanding and speeding time to market.

Some things are worth sharing again. In a 2009 interview with Tim Freeman at Freeman Technologies Tim discusses the fact that powder behavior decisions made during formulation – which parameters to measure, for example – become more critical later on and are critical factors for effective QbD.

At the recent Interphex 2012 show in New York City, Agnes Shanley caught up with Chris Amstutz, Director of Life Science Industry Consulting at Emerson Process Management. In the video below, Amstutz provides a brief look at the recent progression of PAT and QbD in the drug industry.